Monthly Archives: March 2017

New CIMZIA (certolizumab pegol) data in moderate-to-severe plaque psoriasis and psoriatic arthritis presented at American Academy of Dermatology 2017 Annual Meeting

ORLANDO, Fla., March 04, 2017 -- UCB (Euronext:UCB) and Dermira, Inc. (NASDAQ:DERM) today announced 16-week, investigational results from the CIMPASI-1 and CIMPASI-2 Phase 3 trials at the 75th Annual Meeting of the American Academy of Dermatology (AAD) in Orlando, Florida.1 Results from the trials showed that CIMZIA (certolizumab pegol) demonstrated significant improvements in patients with moderate-to-severe chronic plaque psoriasis versus placebo. In addition to previously reported co-primary endpoints, new data presented in an oral presentation at AAD showed the percentage of patients who achieved 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 90). Additionally, data analyses from the RAPID-PsA Phase 3 study were presented evaluating the long-term effect of CIMZIA in adult patients with active psoriatic arthritis (PsA).

The 16-week primary results from CIMPASI-1 and CIMPASI-2 showed that treatment with CIMZIA provided significant benefit to patients living with chronic plaque psoriasis, which is important given that the disease is historically difficult to treat and therefore requires multiple treatment options, said Alice Gottlieb, M.D., Ph.D., Professor of Dermatology, Department of Dermatology, New York Medical College, at Metropolitan Hospital and lead presenter of the data.

The CIMPASI-1 and CIMPASI-2 clinical results presented today support our belief that CIMZIA may one day benefit people living with moderate-to-severe plaque psoriasis, said Luis Pea, chief development officer at Dermira. We are committed to providing patients with access to a new treatment option for psoriasis that may also one day contribute to improvements in their overall quality of life.

Were pleased to present the clinical results from CIMPASI-1, CIMPASI-2, and RAPID-PsA at AAD this year, said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB. At UCB, we are driven foremost by providing value to patients, and these results demonstrate the breadth of our immunology portfolio for people living with plaque psoriasis and psoriatic arthritis. We look forward to continuing our partnership with Dermira to bring CIMZIA to these patients."

The results of the initial 16-week treatment period of CIMPASI-1 and CIMPASI-2 offer important insights for the potential use and the value of CIMZIA in adult patients with moderate to severe chronic plaque psoriasis. Researchers reported that CIMZIA showed clinically meaningful improvements in the PGA, PASI 75 and PASI 90 endpoints at week 16 compared to placebo at both treatment doses (400mg, 200mg).

Topline results from CIMPASI-1 and CIMPASI-2 were previously announced. The identically designed trials evaluated the percentage of patients who achieved a 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), as well as the percentage of patients achieving at least a two-point improvement on a five-point Physicians Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.2

Researchers reported that the most frequent adverse events (AEs) in CIMPASI-1 and CIMPASI-2 through week 16 were upper respiratory tract infections, and serious AEs were infrequent. The adverse event profile across both trials appeared consistent with the adverse event profiles observed with CIMZIA in other indications.2 CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

CIMPASI-1 16-week Results1

CIMPASI-2 16-week Results1

Additional data reported from a key secondary endpoint also found that patients receiving the 400mg and 200 mg dose reported significant improvements in their quality of life compared to patients who received placebo only. CIMZIA showed a mean improvement from baseline in the Dermatology Life Quality Index (DLQI) score compared to placebo, at both doses in both the CIMPASI-1 (decrease of 10.2 at 400 mg and 9.3 at 200 mg vs. 3.3; p<0.001) and CIMPASI-2 (decrease of 10.0 at 400 mg and 10.4 at 200 mg vs. 3.8; p<0.001) clinical trials, at week 16.

A decrease in a patients DLQI score translates to overall improved satisfaction in the management of their skin condition. DLQI is a widely used and recognized quality of life measurement instrument frequently used across many dermatologic conditions.

RAPID-PsA Results3,4,5

Additionally, three post-hoc data analyses from the RAPID-PsA four-year open label extension study were presented, providing insight into the long-term impact of CIMZIA on psoriatic arthritis (PsA) patients. RAPID-PsA is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of CIMZIA. The results of RAPID-PsA were:

About Psoriasis

Psoriasis is a common, chronic, immune-mediated inflammatory disorder with primary involvement of the skin. It affects nearly three percent of the worlds population, or approximately 125 million people worldwide. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary, but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails.6

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a condition involving joint inflammation (arthritis) that usually occurs in combination with a skin disorder called psoriasis. Signs and symptoms of PsA include stiff, painful joints with warmth and swelling in the joints and surrounding tissues. In most people with PsA, psoriasis appears before joint problems develop. In some cases, psoriatic arthritis develops prior to the skin changes. Left untreated PsA can be a disabling disease. PsA affects an estimated 3.4 to 8 per 100,000 people. Between 6 and 42 percent of people with psoriasis develop psoriatic arthritis. Psoriasis affects nearly three percent of the worlds population, or approximately 125 million people worldwide.7,8

About Cimzia In the US Cimzia is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

Cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. See important safety information including risk of serious bacterial, viral and fungal infections and tuberculosis below.

Important Safety Information about Cimzia in the US

Risk of Serious Infections and Malignancy

Patients treated with Cimzia are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:

The risks and benefits of treatment with Cimzia should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cimzia, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member. Cimzia is not indicated for use in pediatric patients.

Patients treated with Cimzia are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.

Treatment with Cimzia should not be initiated in patients with an active infection, including clinically important localized infections. Cimzia should be discontinued if a patient develops a serious infection or sepsis. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g., corticosteroids or methotrexate) may be at a greater risk of infection. Patients who develop a new infection during treatment with Cimzia should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

Malignancies

During controlled and open-labeled portions of Cimzia studies of Crohns disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 Cimzia-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients. In studies of Cimzia for Crohns disease and other investigational uses, there was one case of lymphoma among 2,657 Cimzia-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. In Cimzia RA clinical trials (placebo-controlled and open label), a total of three cases of lymphoma were observed among 2,367 patients. This is approximately 2-fold higher than expected in the general population. Patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of TNF blocker therapy in the development of malignancies is not known.

Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy 18 years of age), of which Cimzia is a member. Approximately half of the cases were lymphoma (including Hodgkins and non-Hodgkins lymphoma), while the other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Most of the patients were receiving concomitant immunosuppressants.

Cases of acute and chronic leukemia have been reported with TNF-blocker use. Even in the absence of TNF-blocker therapy, patients with RA may be at a higher risk (approximately 2-fold) than the general population for developing leukemia.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including Cimzia. The majority of reported TNF blocker cases occurred in adolescent and young adult males with Crohns disease or ulcerative colitis. Almost all of these patients had received treatment with the immunosuppressants azathioprine and/or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with Cimzia, especially in these patient types.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including Cimzia. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.

Heart Failure

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cimzia has not been formally studied in patients with CHF. Exercise caution when using Cimzia in patients who have heart failure and monitor them carefully.

Hypersensitivity

Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following Cimzia administration. Some of these reactions occurred after the first administration of Cimzia. If such reactions occur, discontinue further administration of Cimzia and institute appropriate therapy.

Hepatitis B Reactivation

Use of TNF blockers, including Cimzia, has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Some cases have been fatal. Test patients for HBV infection before initiating treatment with Cimzia. Exercise caution in prescribing Cimzia for patients identified as carriers of HBV, with careful evaluation and monitoring prior to and during treatment. In patients who develop HBV reactivation, discontinue Cimzia and initiate effective anti-viral therapy with appropriate supportive treatment.

Neurologic Reactions

Use of TNF blockers, including Cimzia, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barr syndrome. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with Cimzia. Exercise caution in considering the use of Cimzia in patients with these disorders.

Hematologic Reactions

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g., leukopenia, pancytopenia, thrombocytopenia) has been infrequently reported with Cimzia. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia. Consider discontinuation of Cimzia therapy in patients with confirmed significant hematologic abnormalities.

Drug Interactions

An increased risk of serious infections has been seen in clinical trials of other TNF blocking agents used in combination with anakinra or abatacept. Formal drug interaction studies have not been performed with rituximab or natalizumab; however, because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of Cimzia in these combinations. Therefore, the combination of Cimzia with anakinra, abatacept, rituximab, or natalizumab is not recommended. Interference with certain coagulation assays has been detected in patients treated with Cimzia. There is no evidence that Cimzia therapy has an effect on in vivo coagulation. Cimzia may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

Autoimmunity

Treatment with Cimzia may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of lupus-like syndrome develop.

Immunizations

Do not administer live vaccines or live-attenuated vaccines concurrently with Cimzia.

Adverse Reactions

In controlled Crohns clinical trials, the most common adverse events that occurred in 5% of Cimzia patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% Cimzia, 13% placebo), urinary tract infection (7% Cimzia, 6% placebo), and arthralgia (6% Cimzia, 4% placebo). The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for Cimzia and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in 3% of patients taking Cimzia 200 mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respiratory tract infection (6% Cimzia, 2% placebo), headache (5% Cimzia, 4% placebo), hypertension (5% Cimzia, 2% placebo), nasopharyngitis (5% Cimzia, 1% placebo), back pain (4% Cimzia, 1% placebo), pyrexia (3% Cimzia, 2% placebo), pharyngitis (3% Cimzia, 1% placebo), rash (3% Cimzia, 1% placebo), acute bronchitis (3% Cimzia, 1% placebo), fatigue (3% Cimzia, 2% placebo). Hypertensive adverse reactions were observed more frequently in patients receiving Cimzia than in controls. These adverse reactions occurred more frequently among patients with a baseline history of hypertension and among patients receiving concomitant corticosteroids and non-steroidal anti-inflammatory drugs. Patients receiving Cimzia 400 mg as monotherapy every 4 weeks in RA controlled clinical trials had similar adverse reactions to those patients receiving Cimzia 200 mg every other week. The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 5% for Cimzia and 2.5% for placebo.

The safety profile for patients with Psoriatic Arthritis (PsA) treated with CIMZIA was similar to the safety profile seen in patients with RA and previous experience with Cimzia.

The safety profile for AS patients treated with Cimzia was similar to the safety profile seen in patients with RA.

For full prescribing information, please visit http://www.ucb.com

CIMZIA is a registered trademark of the UCB Group of Companies.

About Cimzia in the EU/EEA In the EU, Cimzia in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX.

Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

Cimzia, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising:

Important Safety Information about Cimzia in the EU/EEA Cimzia was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia and post-marketing were viral infections (includes herpes, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis, herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia due to adverse events vs. 2.7% for placebo.

Cimzia is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections or moderate-to-severe heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infections have been reported in patients receiving Cimzia. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia. Treatment with Cimzia must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia if infection becomes serious. Before initiation of therapy with Cimzia, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia.

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia. Carriers of HBV who require treatment with Cimzia should be closely monitored and in the case of HBV reactivation Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.

TNF antagonists including Cimzia may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia should be discontinued and appropriate therapy instituted.

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia.

Adverse reactions of the hematologic system, including medically significant cytopaenia, have been infrequently reported with Cimzia. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia. Consider discontinuation of Cimzia therapy in patients with confirmed significant haematological abnormalities.

The use of Cimzia in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on CIMZIA should be closely monitored for infections.

Cimzia was studied in 325patients with active axial spondyloarthritis (axSpA) in a placebo-controlled clinical trial for up to 30months and in 409patients with psoriatic arthritis (PsA) in a placebo-controlled clinical trial for up to 30months. The safety profile for axSpA and PsA patients treated with Cimzia was consistent with the safety profile in RA and previous experience with Cimzia.

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision 15th December 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf

REFERENCES

About Dermira

Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermiras product pipeline includes three Phase 3 product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com.

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermiras website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.

About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 700 people in approximately 40 countries, the company generated revenue of 3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Dermira Forward-Looking Statements The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the safe harbor created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including the statements that CIMZIA one day benefit patients living with moderate-to-severe plaque psoriasis and contribute to improvements in their overall quality of life. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcomes of Dermiras clinical trials; the outcome of future discussions with regulatory authorities relating to the CIMZIA clinical program; Dermiras dependence on third-party clinical research organizations, manufacturers and suppliers; and Dermiras ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled Risk Factors set forth in Dermiras Annual Report on Form 10-K, Dermiras Quarterly Reports on Form 10-Q and other filingsDermiramakes with theSEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermiras forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

UCB Forward-Looking Statements This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

Human Life Could Be Extended Indefinitely, Study Suggests

Goosebumps, tears and tenderness: what it means to be moved

Are over-the-counter painkillers a waste of money?

Does an anomaly in the Earth's magnetic field portend a coming pole reversal?

Immunotherapy: Training the body to fight cancer

Do vegetarians live longer? Probably, but not because they're vegetarian

Could a contraceptive app be as good as the pill?

Some scientific explanations for alien abduction that aren't so out of this world

Society actually does want policies that benefit future generations

Six cosmic catastrophes that could wipe out life on Earth

Big Pharma Starts Using Cannabis For Making Drugs In Earnest

Do you need to worry if your baby has a flat head?

See the original post:
New CIMZIA (certolizumab pegol) data in moderate-to-severe plaque psoriasis and psoriatic arthritis presented at ... - EconoTimes

SUMMIT, N.J.--(BUSINESS WIRE)--

Celgene Corporation (CELG) today announced that results from its phase 4 UNVEIL trial evaluating OTEZLA (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate plaque psoriasis with a body surface area (BSA) of 5-10 percent, were presented at the American Academy of Dermatology's Annual Meeting in Orlando, Florida.

The UNVEIL study evaluated the clinical efficacy and safety of oral OTEZLA 30 mg twice daily compared with placebo at week 16 in 221 patients with moderate plaque psoriasis [defined as a BSA involvement of 5-10 percent and a static Physician's Global Assessment (sPGA) of 3] who were nave to systemic and biologic therapy. At baseline, more than 80 percent of patients enrolled in the trial had previously received topical therapy. The primary endpoint was the mean percentage change from baseline in the product of PGA and BSA (PGABSA) at week 16. The PGAxBSA composite tool is a simple assessment that has been developed as a measure of clinically meaningful responses of psoriasis patients in clinical trials.

At week 16, patients who received OTEZLA had a significantly greater improvement in mean percentage change from baseline in PGABSA compared with those who received placebo (-48.1 vs. -10.2, respectively; P<0.0001). In addition, a 75 percent or greater improvement in PGABSA score was achieved by 35.1 percent of patients treated with OTEZLA vs. 12.3 percent of patients treated with placebo (P<0.0001). A significantly greater percentage of patients receiving OTEZLA versus placebo achieved a PGA score of 0 (clear) or 1 (almost clear) at week 16 (30.4 percent vs. 9.6 percent; P<0.0001).

In other secondary endpoints, enrolled patients who had scalp psoriasis (n=167), a significantly greater percentage who received OTEZLA achieved a Scalp Physicians Global Assessment score of 0 (clear) or 1 (minimal) with a greater than two-point reduction from baseline compared with placebo (38.0 percent vs. 20.0 percent, respectively; P=0.0178).

Patients with moderate plaque psoriasis are often inadequately treated, and there remains an unmet medical need for safe and effective treatment options in this population, said Dr. Bruce Strober, professor and chair of the Department of Dermatology at UConn Health. While most trials focus on moderate to severe plaque psoriasis, this is the first randomized clinical trial of patients with moderate plaque psoriasis, and the results provide encouraging data for patients.

In a separate pre-specified analysis, patients in UNVEIL reported satisfaction scores based on the Treatment Satisfaction Questionnaire version II that were significantly greater with OTEZLA than placebo in global satisfaction (63.2 vs. 48.7, respectively; P<0.0001) and effectiveness (57.3 vs. 38.8; P<0.0001) at week 16. Patients reported no significant difference versus placebo in terms of convenience (66.9 vs. 65.7; P=NS) or side effects (78.5 vs. 75.0; P=NS).

Adverse events reported in at least five percent of patients taking OTEZLA and greater than placebo in the UNVEIL study were diarrhea (29 percent vs. 16 percent), headache (20 percent vs. 11 percent), nausea (18 percent vs. 10 percent), upper respiratory tract infection (7 percent vs. 4 percent) and vomiting (6 percent vs. 3 percent). The safety and tolerability data for OTEZLA observed in the UNVEIL study were consistent with previously reported data from six phase 3 studies of OTEZLA in psoriasis or psoriatic arthritis; no new safety signals were observed.

OTEZLA is not indicated for the treatment of plaque psoriasis patients with BSA involvement of less than 10 percent or sPGA less than 3.

About UNVEIL

UNVEIL is the first prospective, randomized, controlled study to evaluate the clinical efficacy and safety of OTEZLA in patients with moderate plaque psoriasis (defined as a BSA involvement of 5-10 percent and sPGA of 3 based on a 0 to 5 scale) who were nave to systemic and biologic therapies. Patients (n=221) were randomized 2:1 to receive either OTEZLA 30 mg twice daily or placebo for 16 weeks, followed by an open-label extension phase in which placebo patients were switched to OTEZLA through week 52. All doses were titrated over the first week of treatment. At baseline, more than 80 percent of patients had previously received topical therapy.

Read More

About OTEZLA

OTEZLA (apremilast) 30 mg tablets is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients with psoriasis is not well defined.

INDICATION

Otezla (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

Warnings and Precautions

Depression: Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During clinical trials, 1.3% (12/920) of patients treated with OTEZLA reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of OTEZLA patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on OTEZLA, compared to 0.2% (1/506) on placebo. One patient treated with OTEZLA attempted suicide; one patient on placebo committed suicide.

Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on OTEZLA. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur.

Weight Decrease: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with OTEZLA and in 5% (19/382) of patients treated with placebo. Body weight loss of 10% occurred in 2% (16/784) of patients treated with OTEZLA compared to 1% (3/382) of patients treated with placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA.

Drug Interactions: Apremilast exposure was decreased when OTEZLA was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of OTEZLA efficacy may occur. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.

Adverse Reactions

Adverse reactions reported in 5% of patients were (OTEZLA%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4).

Use in Specific Populations

Pregnancy and Nursing Mothers: OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman.

Renal Impairment: OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information.

Please click here for Full Prescribing Information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com/. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words expects, anticipates, believes, intends, estimates, plans, will, outlook and similar expressions. Forward-looking statements are based on managements current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170305005014/en/

Visit link:
Oral OTEZLA (Apremilast) Demonstrated Significant Improvement ... - Yahoo Finance